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The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical Procedure Masks are manufactured with three layers. The outer layer is made of double spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer which contacts with face is made of double spun-bonded polypropylene (PP) non-woven fabric. The Surgical Masks are single use, disposable device, provided non-sterile.

This document is a 510(k) Summary for a Surgical Mask, not an AI/ML medical device. Therefore, a significant portion of the requested information regarding AI/ML device acceptance criteria and study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The acceptance criteria and performance data provided in this document pertain to the physical and functional characteristics of the surgical mask, as tested against ASTM F2100-19 standards for medical face masks.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test set sample size: Not explicitly stated for each test, but for Fluid Resistance (ASTM F1862M-17), the acceptance criterion mentions "29 out of 32 pass," indicating a test of at least 32 samples.
• Data Provenance: The tests were non-clinical performance tests conducted by the manufacturer, Hunan Triplex Precision Medical Devices Co., Ltd., based in Changsha, Hunan, China. The data would be considered prospective for the purpose of demonstrating compliance for this specific device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is a physical product, not an AI/ML device relying on human expert annotations for ground truth. Testing involves laboratory measurements against established standards.

4. Adjudication method for the test set:

• None applicable. This is non-clinical laboratory testing, not a human reader study requiring adjudication. The results are quantitative measurements against predefined thresholds.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is defined by the established performance standards (e.g., ASTM F2100-19, EN 14683:2019, 16 CFR 1610) and the specific methodologies outlined within those standards for measuring characteristics like fluid resistance, filtration efficiency, differential pressure, and flammability.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. There is no training set.

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